On behalf of people with CF and their families, the CF Foundation has notified the U.S. Food and Drug Administration (FDA) that the unavailability of two pancreatic enzyme supplements has created transition difficulties and concerns for patients taking these supplements.
 
Distribution of the enzymes Pancrecarb^® and Ultrase^® was stopped because these products failed to receive FDA approval by April 28, 2010. This date was the deadline for all pancreatic enzymes on the market to receive approval from the agency, as part of a comprehensive safety and efficacy review of these supplements.
 
Manufacturers were given six years to satisfy requirements set by the FDA. To date, the FDA has approved three enzyme products: ZENPEP^®, Creon^® and Pancreaze^TM. The Foundation is working closely with the FDA to find ways to reduce the burden on individuals with CF who rely on Pancrecarb and Ultrase.
 
In 2004, the FDA launched the review of enzymes, which had previously been unregulated. The Foundation supported this process because of concern that some of the enzymes available at the time were interfering with absorption of food in CF patients, which is life-threatening. In addition, some CF patients required hospitalization.  
 
More than 90 percent of people with cystic fibrosis take enzyme supplements to help absorb food and vitamins. Without pancreatic enzymes, people with CF could not survive.
 
“Our top priority is the safety and health of people with cystic fibrosis, and we continue to work closely with the FDA and our accredited CF care centers to assure patients receive safe and effective therapies,” said Preston W. Campbell, III, M.D. executive vice president for medical affairs for the Cystic Fibrosis Foundation.
 
“We understand the FDA review has caused a difficult transition for some people with CF, and our hope is they will work closely with a cystic fibrosis physician at an accredited CF Foundation care center to find a solution. It is essential that all therapies used by patients be regulated and approved by the FDA to ensure everyone's short-and long-term safety.”
 
At this time, no additional information is available on the timeframe for approval of the remaining enzymes.
 
Additional Resources

• FDA responds to questions about using approved pancreatic enzyme products.